Drug Interaction - Oral Contraceptive

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The purpose of this study is to administer a combined oral contraceptive containing ethinyl estradiol and norgestimate with the HIV treatment of efavirenz to healthy females in order to assess if the concentrations of the oral contraceptives change. The safety of this treatment regimen will also be studied.

Study to Evaluate the Effect of Efavirenz Coadministration on the Pharmacokinetics of the Active Moieties of a Combined Oral Contraceptive Containing Ethinyl Estradiol and Norgestimate in Healthy Female Subjects

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Ages Eligible for Study:

18 Years to 45 Years (Adult)

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

Women of childbearing potential with intact ovarian function who have been on a stable method of oral contraceptives for at least 2 months prior to the start of the study.

Documented acceptable Pap smear within 1 year of the start of the study

BMI of 18-32 kg/m²

Exclusion Criteria:

Males

Subjects with abnormal menstrual cycle within 2 months prior to the start of the study

History of conditions in which oral contraceptives are contraindicated